Customized Root Analogue Implants- A Prospective pilot clinical study.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Clinical and radiographical outcome evaluation of root analogue implant placed to replace single root tooth
Study Overview
Brief Summary
Ten cases with non restorable single root tooth that needed to be extracted will be selected for the study. The data from the patient CT will be converted and 3D models will be generated. The virtual extraction procedure will be carried out in the model. Extraction socket will be evaluated and Root analogue implant will be designed. After the design analysis of the root analogue implant the customized implant will be fabricated in titanium. Provision for the prosthetic components will be provided in root analogue implant. The implant will be sterilized as per standard protocol. The Root Analogue Implant will be placed into the extraction socket after adequate debridement, curettage and irrigation. Clinical and radiographic outcomes (crestal bone loss) will be evaluated at baseline, 07 days, 01 month, 04 months after implant placement..
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •(i) Patients in need of immediate dental implant placement in tooth/teeth with single root (ii) Individuals aged between 18-50 years (iii) ASA-1 physical status (American Society of Anaesthesiologists) (iv) Available for necessary post-operative follow up (v) Adequate soft tissue health to obtain primary wound closure.
Exclusion Criteria
- •(i) Smokers (ii) Uncontrolled diabetes/alcoholism (iii) Uncontrolled periodontitis (iv) Presence of purulent exudates at the time of extraction (v) Adjacent soft tissue cellulites and granulation tissue (vi) Presence of severe periodontal bone loss without purulent exudates (vii) Root malformations which may prevent insertion of custom implants (viii) Root length less than 10mm.
Outcomes
Primary Outcomes
Clinical and radiographical outcome evaluation of root analogue implant placed to replace single root tooth
Time Frame: 07 days, 01 month, 04 months
Secondary Outcomes
- efficiency of imaging based 3D design technique used for designing of Root analogue Implant.(12 months)
Investigators
Parvinder Sharma
Army Dental Corps